Hospira LifeCare PCA 3 User manual

Page 1

System Operating Manual

Hospira, Inc., Lake Forest, IL 60045, USA
430-04684-002 (Rev. 01/06)
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Change History

Pages Affected
430-04684-001 (Rev. 1/05)
430-04684-002 (Rev. 01/06)
Initial Release All
Second Release All
430-04684-002 (Rev. 01/06)
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LifeCare PCA 3 Infusion System i

Contents

1) DESCRIPTIVE INFORMATION . . . . . . . . . . . . . . . . 1-1
1.1 P
RODUCT DESCRIPTION . . . . . . . . . . . . . . . . . . . 1-1
NDICATIONS FOR USE . . . . . . . . . . . . . . . . . . . . . 1-2
1.2 I
patient selection . . . . . . . . . . . . . . . . . . . . . . . . 1-2
user qualification . . . . . . . . . . . . . . . . . . . . . . . . 1-3
1.3 C
ONTRAINDICATIONS FOR USE . . . . . . . . . . . . . . . 1-3
1.4 C
ONVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
warnings, cautions, and notes . . . . . . . . . . . . . . 1-4
1.5 D
EFINITIONS (GENERAL AND CLINICAL). . . . . . . . . 1-6
RECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
1.6 P
artifacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8
general . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9
programming . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
loading dose/dose limits . . . . . . . . . . . . . . . . . 1-11
operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12
alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13
epidural administration . . . . . . . . . . . . . . . . . . 1-13
battery operation . . . . . . . . . . . . . . . . . . . . . . . 1-14
sets and accessories . . . . . . . . . . . . . . . . . . . . 1-15
2) PRINCIPLES OF OPERATION . . . . . . . . . . . . . . . . 2-1
EATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
2.1 F
drug recognition . . . . . . . . . . . . . . . . . . . . . . . . 2-2
modes of delivery . . . . . . . . . . . . . . . . . . . . . . . 2-2
programming . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
bio medical . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
other features . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
2.2 A
DMINISTRATION EQUIPMENT . . . . . . . . . . . . . . . 2-4
administration sets . . . . . . . . . . . . . . . . . . . . . . 2-4
2.3 P
RINTER KITS . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
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3) EQUIPMENT DESCRIPTION . . . . . . . . . . . . . . . . . . 3-1
3.1 C
OMPONENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
3.2 O
PERATING BUTTONS & KEYS . . . . . . . . . . . . . . . 3-4
4) BASIC OPERATION . . . . . . . . . . . . . . . . . . . . . . . . 4-1
4.1 G
ETTING STARTED . . . . . . . . . . . . . . . . . . . . . . . 4-1
unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
connecting the patient pendant . . . . . . . . . . . . 4-1
system self-tests . . . . . . . . . . . . . . . . . . . . . . . . 4-2
data retention . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
PERATING THE PCA 3 . . . . . . . . . . . . . . . . . . . 4-3
4.2 O intravenous epidural
OADING VIAL . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
4.3 L
DJUSTING SETTINGS . . . . . . . . . . . . . . . . . . . . . 4-7
4.4 A
changing alarm volume . . . . . . . . . . . . . . . . . . . 4-8
changing contrast of main display . . . . . . . . . . . 4-9
changing or confirming time and date . . . . . . . . 4-9
4.5 G
UIDED START-UP FOR PREFILLED VIALS . . . . . . 4-12
purging the system . . . . . . . . . . . . . . . . . . . . . 4-13
loading dose. . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
4.6 G
UIDED START-UP FOR CUSTOM VIALS . . . . . . . 4-17
PCA administration . . . . . . . . . . . . . 4-3
PCA administration . . . . . . . . . . . . . . . . 4-4
5) SELECT MODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
5.1 M
ODES OF DELIVERY . . . . . . . . . . . . . . . . . . . . . 5-1
protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
PCA only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
continuous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
PCA+continuous . . . . . . . . . . . . . . . . . . . . . . . . 5-2
ROGRAMMING PCA ONLY . . . . . . . . . . . . . . . . . 5-3
5.2 P
5.3 C
ONTINUOUS MODE . . . . . . . . . . . . . . . . . . . . . . 5-7
5.4 PCA + C
ROTOCOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16
5.5 P
5.6 D
OSE LIMIT (1 OR 4 HOUR) . . . . . . . . . . . . . . . . 5-18
ONTINUOUS MODE . . . . . . . . . . . . . . . 5-10
dose limit calculation . . . . . . . . . . . . . . . . . . . . 5-18
programming the 4 (or 1) hr dose limit. . . . . . . 5-20
to program a dose limit . . . . . . . . . . . . . . . . . . 5-20
to program
NO dose limit . . . . . . . . . . . . . . . . . 5-21
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to clear or change dose limit . . . . . . . . . . . . . . 5-22
clearing the history & Rx settings. . . . . . . . . . . 5-23
5.7 U
SING REVIEW SCREENS . . . . . . . . . . . . . . . . . . 5-24
HANGING SETTINGS DURING SETUP . . . . . . . . 5-25
5.8 C
5.9 S
TOPPING INFUSION OR TURNING PUMP OFF . . . 5-26
5.10 M
5.11 C
5.12 P
5.13 P
5.14 D
5.15 H
6) TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . 6-1
6.1 S
6.2 P
6.3 S
6.4 A
AKING CHANGES AFTER SETUP . . . . . . . . . . 5-27
to review current settings . . . . . . . . . . . . . . . . 5-27
to change settings . . . . . . . . . . . . . . . . . . . . . . 5-28
to clear shift totals . . . . . . . . . . . . . . . . . . . . . . 5-29
to change a vial . . . . . . . . . . . . . . . . . . . . . . . . 5-30
to add a supplemental loading dose . . . . . . . . 5-32
HECKING HISTORY & SETTINGS . . . . . . . . . . . 5-33
RINTER SETUP . . . . . . . . . . . . . . . . . . . . . . . . 5-34
RINTING EVENT HISTORY LOG . . . . . . . . . . . . 5-39
OWNLOADING TO A PC. . . . . . . . . . . . . . . . . . 5-40
ISTORY AND EVENT LOG . . . . . . . . . . . . . . . . 5-43
TATUS MESSAGES . . . . . . . . . . . . . . . . . . . . . . 6-1
UMP ALARM SYSTEM . . . . . . . . . . . . . . . . . . . . . 6-2
ILENCING AN ALARM . . . . . . . . . . . . . . . . . . . . . 6-3
LARMS AND MESSAGES . . . . . . . . . . . . . . . . . . . 6-4
7) MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
7.1 P
UMP STORAGE . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
LEANING AND SANITIZING . . . . . . . . . . . . . . . . . 7-1
7.2 C
ATTERY MAINTENANCE . . . . . . . . . . . . . . . . . . . 7-3
7.3 B
service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
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8) SPECIFICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
8.1 S
TORED OCCLUSION VOLUME . . . . . . . . . . . . . . . 8-4
8.2 T
IME FROM OCCLUSION TO ALARM . . . . . . . . . . . . 8-4
ELIVERY RATE ACCURACY . . . . . . . . . . . . . . . . . 8-4
8.3 D
trumpet curves . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
example . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
8.4 T
RUMPET CURVES . . . . . . . . . . . . . . . . . . . . . . . . 8-7
9) PRESCRIPTION DELIVERY LIMITS . . . . . . . . . . . . 9-1
10) WARRANTY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
© Hospira, Inc. All Rights Reserved
This document and the subject matter disclosed herein are proprietary information. Hospira retains all the exclusive rights of dissemination, reproduction, manufacture and sale. Any party using this document accepts it in confidence, and agrees not to duplicate it in whole or in part nor disclose it to others without the written consent of Hospira.
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1) Descriptive Information

The LifeCare® PCA 3TM Infusion System is the newest Hospira
LifeCare PCA 3 system can be used in a wide range of clinical settings, including but not limited to:
®
PCA device. Like its predecessor, the PCA Plus II, the
General Floor Labor/Delivery/
Post Partum
Medical/Surgical Operating Room Oncology
Critical Care Units
The PCA 3 Infusion pump allows clinicians to administer or patients to self-administer, analgesia safely and effectively within clinician programmed limits. The epidural route can be used to provide anesthesia or analgesia.
Post Anesthesia Care Unit (PACU)
Burn Unit
Pediatrics

1.1 Product Description

The primary feature of the PCA 3 is the bar code reader, which is designed to automate drug identification. Other enhancements include new programming features, a numeric keypad to directly enter programming values, and a device weight of less than 12 pounds.
The PCA 3 system includes a microprocessor based infusion device with keypad controls, patient pendant, a bar coded drug vial, and a compatible administration set (see Section 2.3 for list of compatible sets). The pump has a serial port for connection to a computer or printer, and the software is field upgradeable. It is intended to operate on AC power, but an internal battery is provided to maintain operation for short periods of time when AC power is not available.
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1- 2 1) Descriptive Information
The vials are single-use, bar coded and prefilled with a prescription drug by filled by the hospital pharmacy.
The PCA 3 system is capable of the following modes of delivery:
Hospira, or sterile and empty to be custom-
PCA ONLY
CONTINUOUS ONLY
PCA+CONTINUOUS
The PCA 3 system also provides the ability to store frequently used prescriptions called Protocols. The protocols are only available for the service mode by a hospital-designated authority.
Hospira pre-filled vials and must be set up through

1.2 Indications for Use

PCA is a method of pain management that permits patients to treat their pain by self-administering doses of analgesics. PCA can be used to manage all types of pain, but is most commonly used to manage acute pain.

PATIENT SELECTION

Patients selected for use of PCA should be able to understand the relationship between pain, pushing the PCA patient pendant and pain relief, and can physically self-administer a PCA dose using the patient pendant.
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WARNING
FOR EPIDURAL USE, ADMINISTER ONLY ANESTHETICS/ANALGESICS APPROVED FOR EPIDURAL ADMINISTRATION (AS INDICATED OR ALLOWED BY THE DRUGS’ FDA APPROVED LABELING). EPIDURAL ADMINISTRATION OF DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT.

USER QUALIFICATIONS

All clinicians should be appropriately trained on programming of the PCA 3 pump prior to use.
The PCA 3 is intended for use at the direction or under the supervision of licensed physicians or certified healthcare professionals. They must be trained in the use of the pump, administration of parenteral and epidural fluids and drugs, and the prevention of related IV complication and precautions to prevent accidental infusion of air. Training should emphasize the assessment and monitoring of patients receiving potent analgesic medications, and the appropriate treatment for possible adverse reactions.

1.3 Contraindications For Use

The PCA 3 should not be used for patient controlled analgesia by patients who do not have the cognitive ability to understand the use of self-administered pain medication nor have the physical capacity to operate the patient pendant, if required.
Drugs not compatible with silicone rubber or PVC plastic, or not stable under infusion conditions, should not be used with this system.
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1- 4 1) Descriptive Information

1.4 Conventions

This section describes the conventions used throughout this manual, as follows:
CONVENTION APPLICATION EXAMPLE
Italic Reference to a
section, figure, or table
Function or mode specific instructions
[BRACKETED ALL-CAPS]
ItalicSmallcaps> Softkey Options C
Initial Caps lowercase
Bold Emphasis ...sets are
Keys or buttons on the device are displayed in [BRACKETED ALL-CAPS] or with a graphic.
Screen displays and device labels (as appropriate)
(See Section 3-1,
Components)
Primary Only: Attach an empty container.
[START/PAUSE]
or
HOOSE>
Therapy
Dose Calculation
supplied Sterile
and are for....

WARNINGS, CAUTIONS, AND NOTES

Alert messages used throughout this manual are described below. Pay particular attention to these messages.
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WARNING
A WARNING MESSAGE CONTAINS SPECIAL SAFETY EMPHASIS AND MUST BE OBSERVED AT ALL TIMES. FAILURE TO OBSERVE A WARNING MESSAGE IS POTENTIALLY LIFE THREATENING.
CAUTION: A
PROCEDURE
PREVENT IRREVERSIBLE PRODUCT DAMAGE OR
COULD HARDWARE COULD RESULT IN SERIOUS PATIENT OR USER INJURY.
CAUTION USUALLY APPEARS IN FRONT OF A
OR STATEMENT. IT CONTAINS INFORMATION THAT
FAILURE. FAILURE TO OBSERVE A CAUTION
NOTE: A Note highlights information that helps explain a
concept or procedure.
This symbol directs the user to consult accompanying documents.
NOTE: Figures are rendered as graphic representations to approximate the actual product. Therefore, figures may not exactly reflect the product.
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1- 6 1) Descriptive Information

1.5 Definitions (General and Clinical)

TERM DEFINITION
1 Hour Dose Limit Programmed parameter specifying
the maximum amount of drug that can be administered in a rolling (continuously advancing) one hour time period.
4 Hour Dose Limit Programmed parameter specifying
the maximum amount of drug that can be administered in a rolling (continuously advancing) four hour time period.
Accuracy The degree to which the instrument
is capable of delivering the volume of analgesic drug that is displayed or targeted to be delivered. Accuracy shall be specified as the maximum allowable delivery error from a targeted or displayed value (see product specification, Section
9).
Continuous Infusion therapy characterized by a
constant fixed-rate dose.
Custom Syringe or Vial
Default Generally refers to the factory
History Displays Parameter Settings, Dose
Bar coded Hospira sterile empty vial which is custom-filled by a licensed pharmacy.
setting for parameters or options.
History and Event Log. Also provides access to Print History softkey.
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TERM DEFINITION
Lockout Interval Programmed time interval
specifying the minimum time that must pass after a PCA dose or Loading Dose is administered before the next PCA dose can be infused. The bolus requests made during this period are not delivered.
Loading Dose An optional dose delivered before
starting normal function of the pump (or thereafter by unlocking the door).
Occlusion Inability of the instrument to infuse
fluid to the patient. Possible causes of occlusions include kinked tubing, plugged tubing, etc.
Maximum Occlusion Pressure
Patient Pendant Hand-held pendant connected to
PCA mode Infusion therapy characterized by
PCA 3 Vial Bar coded vial compatible with the
PCA 3 Instrument Programmable patient controlled
PCA 3 Set Tubing which connects the PCA 3
The maximum pressure observed in response to a patient line occlusion.
the instrument that allows the patient to request a bolus PCA dose by pressing a button.
bolus doses administered on patient demand subject to a lockout interval and, optionally, a 1 or 4 hour dose limit.
PCA 3 instrument that is either prefilled or custom filled with a drug.
infusion pump.
Vial to the patient.
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1- 8 1) Descriptive Information
TERM DEFINITION
Prime Manually removing air from the
syringe and line.
Purge Running the mechanism to remove
system slack when a new vial/ injector is installed. (The system must be primed first and disconnected from the patient.)
Warning An indication to advise the
clinician:
A) of a possible dangerous condition such as a low battery
B) that an attempt has been made to use a function in the wrong sequence, wrong time, or with the wrong values, such as an invalid key attempt

1.6 Precautions

Product damage may occur unless proper care is
exercised during the unpacking and setup process. The battery may not be fully charged upon receipt.

ARTIFACTS

Nonhazardous, low-level electrical potentials are
commonly observed when fluids are administered using infusion devices. These potentials are well within accepted safety standards, but may create artifacts on voltage-sensing equipment such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is associated with the infusion rate. If the monitoring machine is not operating correctly or has loose or defective connections to its sensing electrodes, these artifacts may be accentuated so as to simulate actual
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physiological signals. To determine if the abnormality in the monitoring equipment is caused by the infusion device instead of some other source in the environment, set the infusion device so that it is temporarily not delivering fluid. Disappearance of the abnormality indicates that it was probably caused by the electronic noise generated by the infusion device. Proper setup and maintenance of the monitoring equipment should eliminate the artifact. Refer to the appropriate monitoring equipment system documentation for setup and maintenance instructions.
The PCA 3 system is designed to operate normally in the
presence of most encountered electromagnetic interference (EMI) conditions. In the event of extreme levels of interference, such as those encountered next to an electrosurgical generator, it is possible that the normal operation of a sensor or microcomputer might be disrupted. Even in this event, the outcome would likely be a false alarm or detected system malfunction and would not result in a hazard to patient or clinician.
Use of radio frequency emitting devices such as cellular
telephones and 2-way radios in close proximity of this device may affect its operation.

GENERAL

Possible explosion hazard exists if used in the presence
of flammable anesthetics.
Potent analgesic medications are used with this device.
Refer to drug package insert for precautions and possible adverse reactions.
Refer to analgesic package enclosure for possible
incompatibility with fluid or drug being delivered through the IV line.
Coupling together of more than one pump into one
patient line may significantly affect the infusion rate of at least one of the pumps.
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1- 10 1) Descriptive Information
Do not use sharp objects such as pens, scissors, or
fingernails to press keys. Such objects may damage keys and cause a malfunction.
Arrange tubing, cords, and cables to minimize the risk of
patient strangulation or entanglement.
Failure to use Hospira vials and Hospira PCA sets with
integral anti-siphon valve may cause an inaccurate dose delivery to the patient.
The system must be primed prior to purging. Remove all
air from vial before placing into pump.
Always close slide clamp on PCA administration set
before removing or replacing syringe, and before discontinuing infusion.
Patient must be disconnected from the PCA set before
the purge cycle.
Vial and injector must be securely locked into the infuser
before beginning delivery.

PROGRAMMING

WARNING
FOR CUSTOM SYRINGES, CONFIRM THAT THE DISPLAYED CONCENTRATION (MG/ML) OR (MCG/ ML) EXACTLY MATCHES THE CONCENTRATION VALUE AND DRUG NAME ON THE SYRINGE. IF THEY DO NOT MATCH, UNDER/OVERDOSAGE MAY RESULT.
In the CONTINUOUS and PCA+CONTINUOUS modes, if a
purge is not performed after a syringe change, the pump automatically performs a small system compliance step
to remove slack when the pressed (with door locked). Although fluid is not normally delivered to the patient during the compliance step, under some conditions up to 0.3 mL of fluid may be delivered. If 0.3 mL of fluid represents a hazard to the patient, the set should be disconnected during this operation.
[START/PAUSE] key is
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At flow rates less than 0.5 mL/hr, there may be a
significant delay before flow is established if system is not purged.
Selections are rounded up to the nearest tenth of a digit
for mg/mL values or to the nearest digit for mcg/mL values.

LOADING DOSE/DOSE LIMITS

A loading dose is included in the 4-hour (or 1) dose limit
calculation ONLY if administered after the 4-hour dose limit has been programmed. If the loading dose is administered prior to setting the 4-hour dose limit, it will NOT be included in the 4-hour dose limit calculation. The loading dose is always included in the total dose delivered.
A supplemental “booster” dose can be delivered at any
time during setup or operation, even if the 4-hour dose limit is already reached or will be exceeded after delivery.
Setting a new 4-hour dose limit will not erase the
previous 4-hour dose history.
The concentration can only be changed by removing and
re-inserting a custom vial or by turning the pump OFF then ON again. Once the concentration is programmed and confirmed, it cannot be changed without performing one of these two actions. If the concentration is changed, the current settings and consequently the dose limit accumulation are cleared.
Partial boluses can be the result of interrupting delivery
by pressing [START/STOP] (PCA + Cont.), opening the door (PCA Only), loss of power, reaching the dose limit, emptying the vial, or a malfunction alarm.
If the loading or supplemental “booster” dose causes the
4-hour dose limit to be exceeded, the complete dose will still be delivered. The volume beyond the 4-hour dose limit will count towards the “next” rolling 4-hour dose limit.
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Always monitor the PCA 3 when delivering medication
with the door open.
Patient Pendant is only to be pressed by the intended
patient.

OPERATION

Perform close assessment and monitoring of patients
receiving potent analgesic medication for possible adverse reactions.
The PCA 3 is not intended to be used for frequent, long-
term portable operation. Keep plugged into a properly grounded AC receptacle whenever possible, and reserve battery power for temporary portable operation and emergency backup. If the AC receptacle is in doubt, use battery power.

MAINTENANCE

Always confirm bar code reader window is clean. Blood,
fingerprints, condensation, and other elements may obstruct the view of the bar code reader. Elements on the window (other than scratches) can be cleaned by using one of the recommended cleaning solutions in the
Section 7, Maintenance.
Window scratches cannot be wiped clean and will
probably lead to window replacement.
To avoid mechanical or electrical damage, do not
immerse the pump in any fluids or cleaning solutions.
Some cleaning and sanitizing compounds may slowly
degrade components made from some plastic materials. Using abrasive cleaners or cleaning solutions not recommended by Hospira may result in product damage. Do not use compounds containing combinations of isopropyl alcohol and dimethyl benzyl ammonium chloride.
Do not sterilize by heat, steam, ETO, or radiation.
Do not place the PCA 3 in service if it fails the self-test.
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Hospira will be responsible for the effect on safety,
reliability, and performance of this device only if: adjustments, modifications, or repairs are performed by persons authorized by Hospira; the electrical setup at the point of use complies with appropriate local requirements; and the device is used in accordance with the instructions for use identified in this operating manual.

ALARMS

If the MALFUNCTION alarm sounds, press the [ON/OFF]
key to turn the pump off. Then turn the pump back on. If the malfunction alarm repeats, remove the pump from service.

EPIDURAL ADMINISTRATION

Recommended use of the epidural route is to provide
anesthesia or analgesia for periods up to 96 hours.
It is strongly recommended that the epidural infusion
system be prominently identified as EPIDURAL. Failure to identify the infusion system as epidural could result in incorrect administration of intravenous rather than epidural formulations. In addition, failure to identify the epidural infusion system could result in confusion with other infusion systems delivering concomitant intravenous formulations.
This device can be used to administer only those
anesthetics/analgesics approved for epidural administration (as indicated or allowed by the drugs’ FDA approved labeling). Epidural administration of drugs other than those indicated for epidural use could result in serious injury to the patient.
For epidural administration, the use of pump sets
without Y-sites, and "epidural" stickers indicating ongoing epidural administration are recommended.
Administration of drugs via the epidural route should be
limited to personnel familiar with associated techniques
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1- 14 1) Descriptive Information
and patient management problems. Proper epidural placement of the catheter is essential since catheter migration could result in intravascular or intrathecal administration. Facilities practicing epidural administration must be equipped with resuscitative equipment, oxygen, naloxone, and other resuscitative drugs. Adequate monitoring equipment (e.g., Oximetry) is recommended for continuous monitoring of the patient during epidural administration. Patients must be observed frequently for side effects in a fully-equipped and staffed environment for at least 24 hours following completion of drug administration by the epidural route. DELAYED RESPIRATORY DEPRESSION FOLLOWING CONTINUOUS EPIDURAL ADMINISTRATION OF PRESERVATIVE-FREE MORPHINE SULFATE HAS BEEN REPORTED.
The epidural space has 58 openings through which fluid
can exit. Pressure buildup during administration is transient. However, if a large volume of fluid is administered over a short time period, the pressure will take longer to return to normal. If overdelivery occurs during administration, observe the patient closely for signs of spinal cord compression (disorientation, headache, transient neuralgias) and drug overdose.

BATTERY OPERATION

WARNING
DISCONNECT AC POWER CORD BEFORE REMOVING BATTERY DOOR.
CAUTION: D
BATTERY MAINTAINED OPERATION
O NOT OPERATE THE PCA 3 WITH THE
REMOVED ON PATIENTS. USE OF A PROPERLY
AND CHARGED BATTERY HELPS ENSURE PROPER
.
The battery may not be fully charged upon receipt.
Connect the PCA 3 to AC power for at least 16 hours.
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LifeCare PCA 3 Infusion System 1- 15
Use AC power whenever possible. Connect to AC power
during storage to ensure a fully charged battery for emergencies.
Always connect the pump to a properly grounded
receptacle unless battery operation is desired. If quality earth grounding source is in doubt, use battery power.
If the low-battery alarm sounds, connect to AC power
immediately.

SETS AND ACCESSORIES

Use Hospira Lifecare PCA Set List 6517 whenever the pump is in CONTINUOUS or PCA+CONTINUOUS modes.
When using PCA or PCA+CONTINUOUS mode, another
fluid line may be attached to the distal backcheck “Y” site. Use Hospira Lifecare PCA Set, List 3559, 6516, or a combination of List 6514 and 6517.
It is recommended that highly viscous solutions and
drugs, colloidal suspensions and emulsions should not be delivered through the inline backcheck valve of the PCA set. Valve functionality may be compromised by the presence of residue.
Refer to vial and set package inserts for precautions and
information on proper handling.
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1- 16 1) Descriptive Information
NOTES
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LifeCare PCA 3 Infusion System 2- 1

2) Principles of Operation

The PCA 3 Infuser is a portable infusion pump that allows a patient to self-administer analgesia within programmed limits as well as providing continuous infusion of desired drug. Generally, a nurse following a physician’s order programs the infuser with operating parameters, which may include the following:
Loading Dose
Delivery Mode Setting, i.e., PCA, CONTINUOUS, or
PCA+CONTINUOUS
PCA Dose
Lockout Interval
Rate of Continuous Flow
1 or 4 Hour Dose Limit (factory setting 4-hour)
Protocols (Hospital configured settings for prefilled
vials)
Available operating parameters and their allowed ranges are determined based on the confirmed vial and the delivery mode selected. The loading dose and dose limits are optional. This programmed flexibility allows the physician to tailor an effective pain management program unique to each patient.
The PCA 3 can be programmed to deliver either PCA doses (PCA mode), to deliver only a continuous background infusion with no PCA doses permitted (CONTINUOUS mode), or to deliver a continuous rate and allow PCA doses (PCA+CONTINUOUS mode).
Analgesic drugs may be delivered through the PCA 3 intravenously by any of the three modes mentioned above. In addition, Preservative-Free Morphine Sulfate Injection, USP, or other approved analgesic drugs can be administered epidurally through a recommended Low Priming Volume PCA Set without a Y-adapter. The epidural route can be used to provide analgesia by any of the three modes of infuser operation.
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2- 2 2) Principles of Operation
A “lockout” interval controls the frequency with which a patient may receive a PCA dose of analgesic. If the pump is set in the PCA or PCA+CONTINUOUS mode, the patient may request a bolus of analgesic during therapy by pressing a button on the patient pendant, causing the pump to release the specified bolus of analgesic into the IV line. After a Loading or Supplemental “booster” Dose delivery, the patient cannot receive any additional patient requested boluses until the lockout interval has elapsed, assuming the dose limit has not been exceeded (see Section 5.4
for a detailed description of Dose Limits).
The PCA 3 records therapy settings and up to 400 “events” that may occur during the therapy regimen. Events recorded include opening or closing of the security door, start or stop of continuous infusion, an alarm condition, and so on. All event descriptions are preceded with time of occurrence.
The PCA 3 operates on AC or back-up battery power. It attaches and locks to an IV pole and also has a locking security door to prevent tampering.
The alarm system sounds an audible alarm to alert the user to various conditions or a malfunction (see Section 6.3 for a detailed description of alarm messages).
2.1 Features

DRUG RECOGNITION

Bar code reader identifies drug name and concentra-
tion in the vial (prefilled Hospira vials only)
Bar code reader identifies custom-filled vials when
pharmacy-filled vial is used

MODES OF DELIVERY

PCA Only
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LifeCare PCA 3 Infusion System 2- 3
Continuous
PCA + Continuous

PROGRAMMING

Keypad with large numbers, decimal point & icons
for ease of use
Prompting alphanumeric display

BATTERY

8 V Battery
Long battery life (4 hours) for emergency backup and
temporary portable operation

BIO MEDICAL

Serial Communication
Upgradability (Field)
Diagnostics Setup Options
Alarm History
Ability to store protocols for Hospira prefilled vials

OPTIONS

Infusion History

OTHER FEATURES

Microprocessor control
Liquid crystal display (LCD) and Light-Emitting
Diode (LED) display
Panel back illumination
Security Features
Prefilled and Sterile empty vials
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2- 4 2) Principles of Operation

2.2 Administration Equipment

The following sets and catheters are supplied sterile and are for single use only.

ADMINISTRATION SETS

List 3559: PCA Set, Mini-Bore with Integral Anti-
Siphon Valve-SL 170 cm. Approximate Priming Volume 2.3 mL. For use in PCA mode via Intravenous route.
List 6514: PCA Extension Set with Backcheck Valve-
SL 25 cm. Approximate Priming Volume 1.1 mL. For use in conjunction with set 6517 to convert from Continuous to PCA mode via Intravenous route.
List 6516: PCA Set-Long, Mini-Bore with Integral
Anti-Siphon Valve-SL 218 cm. Approximate Priming Volume 2.6 mL. For use in PCA mode when extra length needed via Intravenous route.
List 6517: PCA Continuous Infusion Set, Mini-Bore
with Integral Anti-Siphon Valve-SL 203 cm. Approximate Priming Volume 1.5 mL.
For use in Continuous and PCA+Continuous modes via Intravenous route.
For use in PCA, Continuous, and PCA+Continuous modes via Epidural route.
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LifeCare PCA 3 Infusion System 2- 5

2.3 Printer Kits

List 12406-01:
List 12406-02:
** See current product sales catalog for available drugs **
Complete thermal printer kit includes: printer, connector cable, battery pack, AC adaptor, & paper pack.
Connector cable only
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2- 6 2) Principles of Operation
NOTES
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LifeCare PCA 3 Infusion System 3- 1
d s

3) Equipment Description

3.1 Components
Security Door
Vial Cradle Clips
Bar code Reader Window
Injector
Vial
Cradle Release Mechanism (Holder)
LED
Display
LCD
Display
Softkeys
Door Lock
Keypa
Button
AC
Power
Indicator
Vial Plunger
Basic Layout of Front Panel and Keypad
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Battery
Power
Indicator
Page 30
3- 2 3) Equipment Description
Cradle Release Mechanism
Vial Base
Upper Vial
Retainer
Bar code Reader Window (Vial Bar code must face)
Vial Stopper
Vial Lip
Injector
Injector Flange (Vial Plunger)
Luer-Lock Fitment
Vial Cradle
Clips
Vial Sensor
Switch
(Top Vial
Cradle
Clip)
Lower Vial
Retainer
(Middle
Bracket)
Injector
Flange
Retainer
Injector
Sensor
Switch
(Back of
Retainer)
Vial Cradle Assembly
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LifeCare PCA 3 Infusion System 3- 3
Patient Pendant Jack
Patient Pendant Cable fastener
PCA 3 Patient Pendant (blue handle)
Universal IV Pole Clamp with
Dual Lock
NOTE: Pole Clamp is locked when security door is closed and locked. Unit cannot be removed from IV pole without key.
TM
Printer Connector
Ground Test Point
Patient
Pendant
Button
Battery and Fuse Access Door
AC Cord Connector
Stabilizer foot
Rear Panel
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3- 4 3) Equipment Description

3.2 Operating Buttons & Keys

The [ON/OFF]
ON
OFF
CLR
ENTER
button is used to control the power of the PCA 3 instrument.
The [CLEAR] button is used to clear an entry.
The [ENTER] button is used to select and accept various screen options.
The [EXIT] button is used to return to the
EXIT
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main display from non-programming screens.
Page 33
LifeCare PCA 3 Infusion System 3- 5
The [SILENCE/
SILENCE
V OLUME
START PA USE
HISTORY
VOLUME] button is used to temporarily silence an alarm while correcting a condition or to adjust alarm volume when the pump is in run mode.
The [START/PAUSE] button is used to start or pause a continuous infusion.
The [HISTORY] button is used to display parameter settings, dose history, and event log. It also provides access to the Print History softkey.
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3- 6 3) Equipment Description
The numeric buttons are used to enter values for any field requiring numeric data.
The [DECIMAL POINT] button is
C L R
used for entering numbers with a decimal point. An example would be
10.5 mL. Keys (or Softkeys) are
touchkeys which are located to the right of the main display. They perform a variety of functions correlating to the description displayed on the screen.
An example of a softkey in this manual is
PCA ONLY>
Battery indicator illuminates continuously when pump is running on battery power.
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LifeCare PCA 3 Infusion System 3- 7
AC (mains) power indicator illuminates when pump is plugged into AC power.
LED displays the dose delivered.
When displaying dose delivery in micrograms, a vertical “walking stick” appears on the right side of the display.
When displaying dose delivering in milligrams, the “walking stick” appears on the left side of the display.
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3- 8 3) Equipment Description
PCA 3 Patient Pendant is used by the patient to deliver the drug upon the press of the button.
WARNING
PATIENT PENDANT IS ONLY TO BE PRESSED BY THE INTENDED PATIENT.
If Patient Pendant is partially pressed, a Pendant Fault message will appear. This can be corrected by releasing the button. A PCA bolus will not be delivered during a Pendant Fault condition.
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LifeCare PCA 3 Infusion System 4- 1

4) Basic Operation

4.1 GETTING STARTED
This section details the PCA 3 instrument setup procedures.

UNPACKING

CAUTION: PRODUCT DAMAGE MAY OCCUR UNLESS
PROPER
D T
Inspect the PCA 3 packaging for possible shipping damage. If damage is found, contact the delivery company immediately.
Use care when unpacking the PCA 3. Retain the packing slip and save all packing material in case the PCA 3 is damaged or fails the pump self-test and has to be returned to Hospira.
CARE IS EXERCISED DURING UNPACKING AND SETUP.
O NOT USE THE PCA 3 IF IT APPEARS DAMAGED IN ANY WAY.
HE BATTERY MAY NOT BE CHARGED UPON RECEIPT.
Inspect the PCA 3 thoroughly for damage.
CAUTION: I
CONTACT HOSPIRA.
F THE PCA 3 APPEARS TO BE DAMAGED,

CONNECTING THE PATIENT PENDANT

The Patient Pendant should be plugged into the unit prior to programming.
1) Connect Patient Pendant plug into back of unit opening labeled Patient Control.
2) Tighten connector ring snugly to confirm proper attachment.
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4- 2 4) Basic Operation

SYSTEM SELF-TESTS

Connect the AC power (mains) cord to an AC power receptacle, then confirm that the power plug icon is illuminated on the front of the pump.
A systematic self-testing of the processing, delivery, and safety systems is performed whenever the PCA 3 is turned on, to verify readiness for operation.
CAUTION: D
THE SYSTEM SELF-TESTS.
FAILS
O NOT PLACE THE PCA 3 IN SERVICE IF IT
NOTE: If the quality of earth grounding source is in
doubt, use battery power.
Failure during the Self-Tests will be reported in the Malfunction Log as a Malfunction Condition.
Unlock door and press the [ON/OFF] button, or insert the vial, to turn the power on. Check screen display and listen for a beep to indicate the audio is working. Wait for the self-tests to complete. If successful, put a vial (with a fully primed set) into the pump.
When operating on battery power, a Low Battery message will be displayed informing you of the condition, and prompting you to connect to AC power.
CAUTION: D
BATTERY CHARGED
REMOVED. USE OF A PROPERLY MAINTAINED AND
O NOT OPERATE THE PCA3 WITH THE
BATTERY HELPS ENSURE PROPER OPERATION.
To ensure battery is fully charged, connect the PCA 3 to AC power for a minimum of 16 hours while in the OFF mode.
If an alarm occurs during the power on self-test, identify the alarm message, then take corrective action (see Section 6, Alarms and Troubleshooting).
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LifeCare PCA 3 Infusion System 4- 3
Power the pump ON. If the alarm recurs, remove the PCA 3 from service and contact the hospital biomedical department or your local Hospira representative.

DATA RETENTION

Delivery program settings and programming option selections are retained in memory.
If the PCA 3 has been turned OFF for more than one hour, all delivery settings are cleared and programming option selections are returned to zero and new programming must be entered.

4.2 Operating the PCA 3

INTRAVENOUS PCA ADMINISTRATION

1) Connect the syringe to the set and manually prime set.
2) Attach primary IV set line to recommended PCA set, list #’s 3559, 6516, or 6517 attached to list 6514 via backcheck valve port.
3) Prime IV set and the lower portion of the PCA set, and close the manual clamp on the IV set.
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4- 4 4) Basic Operation

EPIDURAL PCA ADMINISTRATION

NOTE: The administration of drugs is restricted to those
analgesic drugs approved for continuous epidural administration.
Recommended use of the epidural route is for labor and delivery, acute pain control, or post-operative analgesia for periods up to 96 hours.
WARNING
IT IS STRONGLY RECOMMENDED THAT THE EPIDURAL INFUSION SYSTEM BE PROMINENTLY IDENTIFIED AS “EPIDURAL”. FAILURE TO IDENTIFY IT AS EPIDURAL MAY RESULT IN INCORRECT ADMINISTRATION OF INTRAVENOUS RATHER THAN EPIDURAL FORMULATIONS. IN ADDITION, FAILURE TO IDENTIFY THE EPIDURAL INFUSION COULD RESULT IN CONFUSION WITH OTHER INFUSION SYSTEMS DELIVERING CONCOMITANT INTRAVENOUS FORMULATIONS.
FOR EPIDURAL USE, ADMINISTER ONLY ANESTHETICS/ANALGESICS APPROVED FOR EPIDURAL ADMINISTRATION (AS INDICATED OR ALLOWED BY THE DRUGS’ FDA APPROVED LABELING). EPIDURAL ADMINISTRATION OF DRUGS OTHER THAN THOSE INDICATED FOR EPIDURAL USE COULD RESULT IN SERIOUS INJURY TO THE PATIENT.
If patient access device is not indwelling, prime and establish epidurally. Confirm proper placement. Attach recommended low priming volume pump set, without Y-injection sites, to patient access device.
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LifeCare PCA 3 Infusion System 4- 5
CAUTION: EPIDURAL ADMINISTRATION OF DRUGS BY PCA
AND/OR CONTINUOUS MODES SHOULD BE LIMITED TO PERSONNEL PATIENT PLACEMENT CATHETER
INTRATHECAL ADMINISTRATION. FACILITIES PRACTICING
AND CONTINUOUS WITH OTHER EQUIPMENT CONTINUOUS ADMINISTRATION EFFECTS FREQUENTLY IN A FULLY EQUIPPED AND STAFFED ENVIRONMENT COMPLETION
FAMILIAR WITH ASSOCIATED TECHNIQUES AND
MANAGEMENT PROBLEMS. PROPER EPIDURAL
OF THE CATHETER IS ESSENTIAL SINCE
MIGRATION COULD RESULT IN INTRAVASCULAR
EPIDURAL ADMINISTRATION MUST BE EQUIPPED
RESUSCITATIVE EQUIPMENT, OXYGEN, NALOXONE AND
RESUSCITATIVE DRUGS. ADEQUATE MONITORING
(E.G., OXIMETRY) IS RECOMMENDED FOR
MONITORING OF THE PATIENT DURING EPIDURAL
. PATIENTS MUST BE OBSERVED FOR SIDE-
FOR AT LEAST 24 HOURS FOLLOWING
OF EPIDURAL DRUG ADMINISTRATION.
CAUTION: D
FOLLOWING PRESERVATIVE REPORTED
ELAYED RESPIRATORY DEPRESSION
CONTINUOUS EPIDURAL ADMINISTRATION OF
-FREE MORPHINE SULFATE HAS BEEN
.
If overdelivery occurs during administration, observe the patient carefully for signs of the following:
Compression on spinal cord (disorientation, headache, or transient neuralgia)
Drug overdose
The epidural space has 58 openings through which fluid can exit. Pressure build-up during administration is transient. However, if a large volume of fluid is administered over a short period, the pressure will take longer to return to normal.
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4- 6 4) Basic Operation

4.3 Loading Vial

WARNING
FAILURE TO USE COMPATIBLE HOSPIRA VIAL/ INJECTOR AND HOSPIRA PCA SETS WITH INTEGRAL ANTI-SIPHON VALVE MAY CAUSE AN INACCURATE DOSE DELIVERY TO THE PATIENT.
1. Squeeze Cradle Release Mechanism together at the top of the holder and move to the uppermost position.
1
4
1
2
1
DRUG NAME
NOTE: Always confirm bar
code reader window is clean before inserting vial.
2. Hold the vial with the graduated markings facing the clinician. This will ensure the vial bar code label faces the bar code reader on the right side of the vial compartment.
3
CAUTION: DO NOT LOAD VIAL
UPPER VIAL CLIP FIRST.
INTO
V
IAL LIP MAY CRACK OR CHIP.
3. Insert bottom of glass vial into the middle black bracket.
5
4. Gently press upper end of glass vial into upper black bracket.
5. Squeeze the top of the Cradle Release Mechanism and move down until the vial injector snaps into the bottom bracket.
6. Select
CONTINUE>.
7. If vial bar code is not read by pump, slowly rotate the vial and position with the bar code on the right until bar code has been read.
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LifeCare PCA 3 Infusion System 4- 7
CAUTION: VIAL AND INJECTOR MUST BE SECURELY
LOCKED
INTO THE INFUSER BEFORE BEGINNING DELIVERY.
WARNING
CRACKED VIALS MAY NOT SHOW EVIDENCE OF LEAKAGE UNTIL DELIVERY PRESSURE IS APPLIED.
NOTE: If the device is OFF, improper loading of syringe
will turn ON the device and activate a non-silenceable CHECK SYRINGE alarm within 30 seconds after
C
ONTINUE> is selected. Proper loading (engaging injector
flange) will silence the alarm.

4.4 Adjusting Settings

1) Press button to power on the pump. Upon initial
start-up, the self-test begins.
2) Select SYSTEM SETTINGS> to view the Change Settings menu.
LIFECARE PCA 3
SELF TEST
LIFECARE PCA 3
SELF TEST
COMPLETE
RAM . . . . . OK
FLASH . . . OK CPU ID . . . OK
CPU . . . . . OK
TIMER . . . .OK
SYSTEM SETTINGS
CONTINUE
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4- 8 4) Basic Operation
3) Choose the setting to
SELECT
SETTING TO CHANGE
VOLUME
CONTRAST
TIME/DATE
change by selecting the appropriate softkey.
CONTINUE

CHANGING ALARM VOLUME

1) Select VOLUME>.
SELECT SETTING TO CHANGE
VOLUME
CONTRAST
TIME/DATE
CONTINUE
2) Select desired volume,
SELECT ALARM
VOLUME
HIGH
MEDIUM
LOW
CANCEL
SAVE & EXIT
then SAVE & EXIT>.
The current setting will flash at this screen.
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LifeCare PCA 3 Infusion System 4- 9

CHANGING CONTRAST OF MAIN DISPLAY

1) Select CONTRAST>.
SELECT
SETTING TO CHANGE
VOLUME
CONTRAST
TIME/DATE
CONTINUE
2) Select desired adjustment softkey repeatedly until contrast is optimized for viewing.
3) Select SAVE & EXIT>.
ADJUST LCD
CONTRAST TO DESIRED LEVEL
LIGHTER
DARKER
CANCEL
SAVE & EXIT

CHANGING OR CONFIRMING TIME AND DATE

WARNING
CHANGING THE DATE OR TIME WILL CLEAR ALL TOTALS. THE CURRENT PROGRAM WILL REMAIN INTACT WHEN THE TIME/DATE FUNCTION IS ACCESSED. LOCKOUTS OR LIMITS IN PLACE WHEN THE TIME/DATE IS CHANGED WILL REMAIN IN EFFECT.
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4- 10 4) Basic Operation
1) Select TIME/DATE>.
SELECT
SELECT
SETTING
SETTING TO CHANGE
TO CHANGE
VOLUME
CONTRAST
TIME/DATE
CONTINUE
After selecting TIME/DATE>, a warning screen appears to inform you that changing the date or time will clear all totals. The current program will remain intact when the time/date function is accessed. Lockouts or limits in place when the time/date is changed will remain in effect.
2) Warning Screen appears, select CONTINUE>.
WARNING
CHANGING THE
DATE OR TIME
WILL CLEAR ALL
TOTALS
CONTINUE
PREVIOUS
3) Set Time with number
SET TIME WITH
NUMBERS BUTTONS
TOGGLE AM/PM
10:43 PM
buttons. Enter hour as two digits (01:00) and minutes as two digits (01:07 PM). Select AM/PM> to alternate between AM and PM.
AM/PM
NEXT
NOTE: Time can be displayed as 12 or 24 hour clock. The default setting is 12 hour.
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LifeCare PCA 3 Infusion System 4- 11
4) After changing time, select NEXT> to change Date. Set date with numbers buttons.
Current setting for Date will flash.
NOTE: Date must be entered in MM/DD/YY sequence.
SET DATE WITH
NUMBERS BUTTONS
01/15/05
NEXT
5) Select NEXT> again after changing to desired date. This will advance you to the confirmation screen.
6) Select CONFIRM> to confirm the changed settings.
CONFIRM
CURRENT TIME AND DATE SETTINGS
9:21 PM 01/15/05
CONFIRM
CHANGE
CANCEL
7) Then select CONTINUE> to exit the Change System Settings menu and display the Vial Confirmation screen (if vial is loaded properly).
SELECT
SETTING TO CHANGE
VOLUME
CONTRAST
TIME/DATE
CONTINUE
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4- 12 4) Basic Operation

4.5 Guided Start-Up for Prefilled vials

LIFECARE PCA 3
SELF TEST
MORPHINE
1 mg/mL
CONFIRM
1 MG/ML M O R P H I N E P H TO RX
REMOVE VIAL
IF NOT CORRECT
CONFIRM
1) Press button, or load drug vial into cradle, to power
on the pump. Upon initial start-up, the self-test begins.
(See Section 4.3)
This screen will be followed by another displaying all self-test information, including time, date, software version and copyright information. It lasts about 2 seconds. During the self-test, the pump will read the bar code label.
2) Select CONTINUE> to advance to the next screen.
3) Select CONFIRM> to accept the inserted drug or remove the vial if not correct.
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LifeCare PCA 3 Infusion System 4- 13
4) Select either YES> or NO> to clear history and dose settings if pump has been OFF for 1 hour or less.
5) Select CONFIRM> to confirm choice and continue.
A screen will appear confirming History has been cleared.
MORPHINE
1 mg/mL
CLEAR HISTORY AND RX SETTINGS?
YES
MORPHINE
1 mg/mL
CONFIRM CLEAR HISTORY AND RX SETTINGS
CONFIRM
PREVIOUS
NO
6) Select either YES> or NO> to purge the system.
MORPHINE
1 mg/mL
PURGE?

PURGING THE SYSTEM

WARNING
PATIENT MUST BE DISCONNECTED FROM THE PCA SET BEFORE THE PURGE CYCLE.
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YES
NO
Page 50
4- 14 4) Basic Operation
After the pump is turned on, and the self-tests complete, you are prompted to purge the system. Confirm the PCA set is disconnected from the patient’s IV line before pressing Y initiate the purge cycle.
ES> to
Press and hold the P
URGE> key. The flow rate during purging is
approximately 250 mL/hr. As soon as fluid is seen at the end of the administration set, and no air remains in the set, release the key. After the P
URGE> key is released, the purge cycle will stop
and the pump will prompt you to respond if flow was seen. If flow was not seen, the cycle may be repeated until a total of 3 mL has been delivered.
To remove system slack when a new syringe is installed, it is recommended that the pump be purged before beginning operation.
NOTE: The system must be primed before purging. Remove all air from the syringe before putting it into the pump.
NOTE: Drug delivered during the purge cycle is not stored in system memory and will not be displayed.
CAUTION: I
, IF A PURGE IS NOT PERFORMED AFTER A SYRINGE
MODES CHANGE SYSTEM IS PRESSED (WITH DOOR LOCKED). ALTHOUGH FLUID IS NOT NORMALLY COMPLIANCE OF FLUID MAY BE DELIVERED. IF 0.3 ML OF FLUID REPRESENTS A DISCONNECTED
, THE PUMP AUTOMATICALLY PERFORMS A SMALL
COMPLIANCE STEP TO REMOVE SLACK WHEN [START]
HAZARD TO THE PATIENT, THE SET SHOULD BE
N CONTINUOUS AND PCA+CONTINUOUS
DELIVERED TO THE PATIENT DURING THE
STEP, UNDER SOME CONDITIONS UP TO 0.3 ML
DURING THIS OPERATION.
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LifeCare PCA 3 Infusion System 4- 15
7) If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> softkey.
While purging is occurring, the word PURGING will be displayed.
NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3 mL.
Upon release of the P
URGE> softkey,
the display will ask if the purge is complete.
8) Select YES> to continue, or select NO> to purge again until complete.
9) Reconnect Set to patient.
MORPHINE
1 mg/mL
DISCONNECT SET FROM PATIENT
PRESS AND HOLD PURGE KEY
PURGE
PREVIOUS
MORPHINE
1 mg/mL
PURGE COMPLETE?
YES
NO
10) Set Loading Dose (if desired) by selecting YES>.
If NO> is selected, you will go directly to the Select Mode screen. Information on modes can be found in Section 5.

LOADING DOSE

After the drug concentration has been confirmed, an optional loading dose may be programmed to provide an immediate bolus to the patient.
MORPHINE
1 mg/mL
SET LOADING
DOSE?
YES
NO
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4- 16 4) Basic Operation
NOTE: A supplemental (booster) dose can be delivered at any time during operation by opening the door and selecting the L Limit is set and has been reached, using the loading dose function may result in exceeding the dose limit.
OADING DOSE> key. If the 4 (1) Hr Dose
MORPHINE
1 mg/mL
ENTER
LOADING DOSE
THEN PRESS
ENTER BUTTON
0.1 - 10 mg
5 mg
milligrams
PREVIOUS
MORPHINE
1 mg/mL
PRESS
START BUTTON TO INFUSE 5 MG LOADING DOSE
PREVIOUS
11) Enter a Loading Dose within the displayed range.
12) Then press .
ENTER
13) Press button to infuse programmed Loading Dose.
NOTE: If an occlusion condition is
detected, the delivery will stop for 10 seconds. If the occlusion condition still exists at the 10­second mark, then the Occlusion Alarm occurs. Otherwise, the delivery is automatically resumed.
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LifeCare PCA 3 Infusion System 4- 17
Example screen displaying Loading Dose Value as it infuses. Bottom of screen displays text confirming Loading Dose is active. Upon completion, Red LED (above LCD) displays Dose Delivered.
MORPHINE
1 mg/mL
PRESS
PAUSE BUTTON TO STOP
2.5 mg
This will bring you to the Select Mode screen which is described in the next section.
milligrams
INFUSING
LOADING DOSE

4.6 Guided Start-Up for Custom Vials

1) Press button, or load drug vial into cradle, to power
on the pump. Upon initial start-up, the self-test begins.
This screen will be followed by another displaying all self-test information, including time, date, software version and copyright information. It lasts about 2 seconds. During the self-test, the pump will read the bar code label.
LIFECARE PCA 3
SELF TEST
2) Select CONTINUE> to advance to the next screen.
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4- 18 4) Basic Operation
CUSTOM VIAL
CONFIRM
CUSTOM VIAL TO RX
REMOVE VIAL
IF NOT CORRECT
CONFIRM
CUSTOM VIAL
CLEAR
HISTORY
YES
NO
CUSTOM VIAL
CONFIRM
CLEAR HISTORY
3) Select CONFIRM> to accept the inserted drug or remove the vial if not correct.
4) Select either YES> or NO> to clear history and dose settings if pump has been OFF one hour or less.
5) Select CONFIRM> to confirm choice and continue.
A screen will appear confirming History has been cleared.
CONFIRM
PREVIOUS
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LifeCare PCA 3 Infusion System 4- 19
6) Select either YES> or NO> to purge the system.
7) If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> softkey.
While purging is occurring, the word PURGING will be displayed.
NOTE: Purging is recommended to remove system slack when a new vial is inserted. The maximum volume delivered during a purge is 3mL.
CUSTOM VIAL
PURGE?
YES
NO
CUSTOM VIAL
DISCONNECT SET FROM PATIENT
PRESS AND HOLD PURGE KEY
PURGE
PREVIOUS
Upon release of the P
URGE> softkey,
the display will ask if the purge is complete.
8) Select YES> to continue, or select N
O> to purge again
until complete.
9) Reconnect Set to patient.
CUSTOM VIAL
PURGE COMPLETE?
YES
NO
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4- 20 4) Basic Operation
CUSTOM VIAL
SELECT UNITS
OF MEASURE
GRAMS
MILLI
MICROGRAMS
CUSTOM VIAL
ENTER DRUG
CONCENTRATION
THEN PRESS
ENTER BUTTON
1-100 mcg/mL
micrograms
PREVIOUS
10
(mg)
(mcg)
mcg
mL
10) Select desired Units of Measure.
For the purposes of this instruction, Micrograms is selected.
11) Enter desired Drug Concentration within the displayed range.
NOTE: Only whole numbers may
be entered when using micrograms (mcg). If a decimal entry is attempted, the display will inform the user that decimals are not allowed. Press [CLEAR] to zero the value. Then enter a value within the displayed range.
ENTER
CUSTOM VIAL
10 mcg/mL
CONFIRM
10 MCG/ML CONCENTRATION TO PHYSICIAN RX
CONFIRM
PREVIOUS
12) Then press .
13) Confirm Concentration by selecting CONFIRM>.
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LifeCare PCA 3 Infusion System 4- 21
14) Set Loading Dose (if desired) by selecting YES>.
If NO> is selected, you will go directly to the Select Mode screen. Information on modes can be found in Section 5.
15) Enter a Loading Dose within the displayed range.
16) Then press .
ENTER
CUSTOM VIAL
10 mcg/mL
SET LOADING
DOSE?
YES
CUSTOM VIAL
10 mcg/mL
ENTER
LOADING DOSE
THEN PRESS
ENTER BUTTON
1 - 100 mcg
35 mcg
micrograms
PREVIOUS
NO
17) Press button to infuse programmed Loading Dose.
WARNING
ALWAYS MONITOR THE PCA 3 WHEN DELIVERING MEDICATION WITH THE DOOR OPEN.
CUSTOM VIAL
10 mcg/mL
PRESS
START BUTTON TO INFUSE 35 MCG LOADING DOSE
PREVIOUS
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4- 22 4) Basic Operation
CUSTOM VIAL
10 mcg/mL
PRESS
PAUSE BUTTON TO STOP
25 mcg
micrograms
INFUSING
LOADING DOSE
Example screen displaying Loading Dose Value as it infuses. Bottom of screen displays text confirming Loading Dose is active. Upon completion, Red LED (above LCD) displays Dose Delivered.
This will bring you to the Select Mode screen which is described in the next section.
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LifeCare PCA 3 Infusion System 5- 1

5) Select Mode

5.1 Modes of Delivery
The PCA 3 delivers analgesia in one of three modes:
PCA ONLY
•CONTINUOUS
PCA+CONTINUOUS

PROTOCOLS

Pre-programmed settings for the 3 delivery modes, created in the Service Mode for Hospira prefilled drug vials. For information on using the Service Mode, contact Hospira Technical Support Operations at 1-800-241-4002.
NOTE: Protocols not available for Custom Vials.

PCA ONLY

A patient initiated dose can be administered using the patient pendant when the PCA AVAILABLE message appears. After completing the dose, the pump enters either the preset LOCKOUT interval or the DOSE LIMIT REACHED state (if a dose limit has been entered); further delivery is prohibited in both of these conditions.
Partial doses can be the result of interrupting delivery by pressing [START/STOP] (PCA + Cont.), opening the door (PCA Only), loss of power, reaching the dose limit, emptying the vial, or a malfunction alarm.
The screen message will alert the user that PCA is not available and a different audible tone will occur if patient pendant button is pressed (unless deactivated in Service Mode).
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5- 2 5) Select Mode

CONTINUOUS

A programmed continuous infusion is started by pressing the [START/PAUSE] button after the door is closed and locked. The patient pendant is disabled in CONTINUOUS mode. Upon reaching the DOSE LIMIT, if entered, the pump stops drug delivery and the 4 (or 1)-HR LIMIT REACHED message is displayed.

PCA+CONTINUOUS

Infusion is started by pressing the [START/PAUSE] button after the door is closed and locked. A patient initiated PCA dose can be administered using the patient pendant when the PCA AVAILABLE message appears. When the patient-initiated dose is activated, the PCA dose is delivered prior to the CONTINUOUS infusion rate. After the PCA dose is completed, the pump enters the LOCKOUT interval. While in the lockout period, the CONTINUOUS infusion remains in progress, but the patient initiated dose cannot be activated. If a Dose limit state has
been reached, the pump stops drug delivery.
NOTE: In CONTINUOUS or PCA+CONTINUOUS mode,
The [START/PAUSE] button must be pressed within 30 seconds of locking the door or the pump will alarm.
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5.2 Programming PCA Only

For detailed Startup information including Vial Insertion, Clearing Settings, Purging, and setting a Loading Dose, see Section 4.
Also refer to Section 4 for information on adjusting system settings such as contrast and volume.
1) Unlock door and press button, or load drug vial into
LIFECARE PCA 3
SELF TEST
cradle, to power on the pump. Upon initial start-up, the self­test begins.
2) Select CONTINUE> to advance to next programming screen.
3) Select CONFIRM> to accept the inserted drug or remove the vial if not correct.
4) Select either YES> or NO> to clear history and dose settings if pump has been OFF for one hour or less.
5) Select C
ONFIRM> to confirm choice and
continue.
6) Select either Y
ES> or NO> to purge the system.
7) If Y
ES> is selected, disconnect the set from the
patient, and press and hold the P
URGE> softkey.
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5- 4 5) Select Mode
8) Select YES> to continue, or select NO> to purge again until complete.
9) Reconnect Set to patient.
10) Set Loading Dose (if desired) by selecting YES>.
11) Enter a Loading Dose within the displayed range.
12) Then press .
ENTER
13) Press button to infuse programmed Loading Dose.
MORPHINE
1 mg/mL
SELECT
DELIVERY MODE
PCA ONLY
PCA + CONT.
CONTINUOUS
PROTOCOLS
PREVIOUS
14) From the Select Delivery Mode screen, select PCA
ONLY>.
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15) Enter the desired PCA dose using the numeric keypad. (Value range is displayed on screen)
C
If value is entered incorrectly, press
to change value.
16) Then press .
ENTER
L R
MORPHINE
1 mg/mL
ENTER
PCA DOSE
THEN PRESS
ENTER BUTTON
0.1-5 mg
2 mg
milligrams
PREVIOUS
If programming changes need to be made, select PREVIOUS> to return to the previous screen.
17) Enter a lockout Interval value. (Value range is displayed on the screen)
C
If value is entered incorrectly, press to change value.
18) Then press .
ENTER
L R
MORPHINE
1 mg/mL
ENTER LOCKOUT
INTERVAL
THEN PRESS
ENTER BUTTON
5-120 min
10 min
minutes
PREVIOUS
If programming changes need to be made, select P
REVIOUS> to return to
the previous screen.
19) Set a specific dose limit by selecting YES> and advancing to the Dose Limit Enter Value screen. Or select NO> to choose No Dose Limit.
No Dose Limit will be selected for this example.
MORPHINE
1 mg/mL
SET A DOSE LIMIT?
YES
NO
PREVIOUS
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5- 6 5) Select Mode
NOTE: See Section 5.6 Dose Limit (1 or 4 hour) for complete information on this feature.
MORPHINE
1 mg/mL
CONFIRM NO DOSE LIMIT
CONFIRM
PREVIOUS
MORPHINE
1 mg/mL
PCA ONLY
PCA DOSE
LOCKOUT
4 HOUR LIMIT
CONFIRM
PREVIOUS
2 mg
10 min
NO
20) Select CONFIRM> to confirm No Dose Limit selection.
Select PREVIOUS> to return to the previous screen.
21) Select CONFIRM> to confirm settings. Or, select PREVIOUS> to return to the previous screen.
22) Close and lock door. Place key in a secure location. Upon door lock, PCA is available.
23) Patient presses pendant to initiate PCA dose.
NOTE: If an occlusion condition is detected, the delivery
will stop for 10 seconds. If the occlusion condition still exists at the 10-second mark, then the Occlusion Alarm occurs. Otherwise, the delivery is automatically resumed.
Approximately 10 seconds after door is locked, “Door Locked” message will disappear. After delivery of PCA dose, PCA LOCKOUT message appears indicating PCA is locked out.
If Patient Pendant is partially pressed, a Pendant Fault message will appear. This could be corrected by releasing the button.
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LifeCare PCA 3 Infusion System 5- 7
When Dose Limit is reached, a message will be displayed indicating Dose Limit has been reached.

5.3 Continuous Mode

For detailed Startup information including Vial Insertion, Clearing Settings, Purging, and setting a Loading Dose, see Section 4.
Also refer to Section 4 for information on adjusting system settings such as contrast and volume.
1) Unlock door and press button, or load drug vial into
LIFECARE PCA 3
SELF TEST
cradle, to power on the pump. Upon initial start-up, the self­test begins.
2) Select CONTINUE> to advance to next programming screen.
3) Select CONFIRM> to accept the inserted drug or remove the vial if not correct.
4) Select either Y
ES> or NO> to clear history and
dose settings if pump has been OFF one hour or less.
5) Select CONFIRM> to confirm choice and continue.
6) Select either YES> or NO> to purge the system.
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5- 8 5) Select Mode
7) If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> softkey.
8) Select YES> to continue, or select NO> to purge again until complete.
9) Reconnect Set to patient.
10) Set Loading Dose (if desired) by selecting YES>.
11) Enter a Loading Dose within the displayed range.
12) Then press .
ENTER
13) Press button to infuse programmed Loading Dose.
MORPHINE
1 mg/mL
SELECT
DELIVERY MODE
PCA ONLY
PCA + CONT
CONTINUOUS
PROTOCOLS
PREVIOUS
14) From the Select Mode screen, select CONTINUOUS>.
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15) Enter a value using the keypad. (Value range is displayed on screen)
C
If value is entered incorrectly, press
L
R
to change value.
16) Then press .
ENTER
If programming changes need to be made, select P
REVIOUS> to return to the previous screen.
17) Set a specific dose limit by selecting YES> and advancing to the Dose Limit Enter Value screen. Or select NO> to choose No Dose Limit.
No Dose Limit will be selected for this example.
NOTE: See Section 5.6 Dose Limit (1 or 4 hour) for complete
information on this feature.
MORPHINE
1 mg/mL
ENTER
CONT. RATE
THEN PRESS
ENTER BUTTON
0.1-20 mg/hr
2
milligrams
PREVIOUS
MORPHINE
1 mg/mL
SET A DOSE LIMIT?
PREVIOUS
mg hr
YES
NO
18) Select CONFIRM> to confirm No Dose Limit selection.
Select PREVIOUS> to return to the previous screen.
MORPHINE
1 mg/mL
CONFIRM NO DOSE LIMIT
CONFIRM
PREVIOUS
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5- 10 5) Select Mode
MORPHINE
1 mg/mL
CONTINUOUS
PCA DOSE
LOCKOUT
CONT. RATE
4 HOUR LIMIT
CONFIRM
PREVIOUS
2 mg/hr
NONE
19) Select CONFIRM> to confirm settings.
Or, select PREVIOUS> to return to the previous screen.
20) Close and lock door. Place key in a secure location.
21) Press to begin therapy.
Approximately 10 seconds after door is locked and is pressed, “Door Locked” message will disappear.
When Dose Limit is reached, a message will be displayed indicating Dose Limit has been reached.

5.4 PCA + Continuous Mode

For detailed Startup information including Vial Insertion, Clearing Settings, Purging, and setting a Loading Dose, see Section 4.
Also refer to Section 4 for information on adjusting system settings such as contrast and volume.
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1) Unlock door and press button, or load drug vial into
LIFECARE PCA 3
SELF TEST
cradle, to power on the pump. Upon initial start-up, the self­test begins.
2) Select CONTINUE> to advance to next programming screen.
3) Select CONFIRM> to accept the inserted drug or remove the vial if not correct.
4) Select either YES> or NO> to clear history and dose settings if pump has been OFF one hour or less.
5) Select CONFIRM> to confirm choice and continue.
6) Select either YES> or NO> to purge the system.
7) If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> softkey.
8) Select YES> to continue, or select NO> to purge again until complete.
9) Reconnect Set to patient.
10) Set Loading Dose (if desired) by selecting
ES>.
Y
11) Enter a Loading Dose within the displayed
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5- 12 5) Select Mode
range.
12) Then press .
ENTER
13) Press button to infuse programmed Loading Dose.
MORPHINE
1 mg/mL
SELECT
DELIVERY MODE
PCA ONLY
PCA + CONT
CONTINUOUS
PROTOCOLS
PREVIOUS
MORPHINE
1 mg/mL
ENTER
PCA DOSE
THEN PRESS
ENTER BUTTON
0.1-5 mg
2 mg
milligrams
14) From the Select Mode screen, select PCA + CONT.>.
15) Enter PCA dose value using the keypad. (Value range is displayed on screen)
If value is entered incorrectly, press
to change value.
C L R
PREVIOUS
16) Then press .
ENTER
If programming changes need to be
made, select P
REVIOUS> to return to the previous screen.
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17) Enter a Lockout Interval value. (Value range is displayed on screen)
C
If value is entered incorrectly, press
L
R
to change value.
18) Then press .
ENTER
If programming changes need to be made, select P
REVIOUS> to return to the previous screen.
19) Enter a Continuous Rate. (Value range is displayed on screen)
C
If value is entered incorrectly, press
to change value.
20) Then press .
ENTER
L
R
MORPHINE
1 mg/mL
ENTER LOCKOUT
INTERVAL
THEN PRESS
ENTER BUTTON
5-120 min
10 min
minutes
PREVIOUS
MORPHINE
1 mg/mL
ENTER
CONT. RATE
THEN PRESS
ENTER BUTTON
0.1-20 mg/hr
milligrams
PREVIOUS
2
mg hr
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5- 14 5) Select Mode
If programming changes need to be made, select PREVIOUS> to return to the previous screen.
MORPHINE
1 mg/mL
SET A DOSE LIMIT?
PREVIOUS
MORPHINE
1 mg/mL
ENTER 4 HOUR DOSE LIMIT THEN PRESS ENTER BUTTON
2- 80 mg
40 mg
milligrams
PREVIOUS
YES
NO
21) Set a specific dose limit by selecting YES> and advancing to the Dose Limit Enter Value screen. Or select NO> to choose No Dose Limit.
Setting a specific Dose Limit will be selected for this example.
NOTE: See Section 5.6 Dose Limit (1 or 4 hour) for complete
information on this feature.
22) Enter the Dose Limit value using the numeric keypad (the range is displayed on the screen).
C
If value is entered incorrectly, press to change value.
23) Then press .
ENTER
L R
If programming changes need to be made, select PREVIOUS> to return to the previous screen.
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24) Select CONFIRM> to confirm settings.
Or, select PREVIOUS> to return to the previous screen.
25) Close and lock door. Place key in a secure location.
MORPHINE
1 mg/mL
PCA+CONT
PCA DOSE
LOCKOUT
CONT. RATE
4 HOUR LIMIT
CONFIRM
PREVIOUS
2 mg
10 min
2 mg/hr
40 mg
26) Press to begin therapy.
Approximately 10 seconds after door is locked and is pressed, “Door Locked” message will disappear.
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5- 16 5) Select Mode

5.5 Protocols

NOTE: Standard Protocols must be established by
hospital through the Service Mode. Protocols can only be established for Hospira prefilled vials. Only Protocols associated with the inserted drug vial will be available.
For detailed Startup information including Vial Insertion, Clearing Settings, Purging, and setting a Loading Dose, see Section 4.
Also refer to Section 4 for information on adjusting system settings such as contrast and volume.
LIFECARE PCA 3
SELF TEST
1) Unlock door and press button, or load drug vial into
cradle, to power on the pump. Upon initial start-up, the self­test begins.
2) Select CONTINUE> to advance to next programming screen.
3) Select CONFIRM> to accept the inserted drug or remove the vial if not correct.
4) Select either YES> or NO> to clear history and dose settings if pump has been OFF one hour or less.
5) Select CONFIRM> to confirm choice and continue.
6) Select either YES> or NO> to purge the system.
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LifeCare PCA 3 Infusion System 5- 17
7) If YES> is selected, disconnect the set from the patient, and press and hold the PURGE> softkey.
8) Select YES> to continue, or select NO> to purge again until complete.
9) Reconnect Set to patient.
10) Set Loading Dose (if desired) by selecting YES>.
11) Enter a Loading Dose within the displayed range.
12) Then press .
ENTER
13) Press button to infuse programmed Loading Dose.
14) From the Select Mode screen, select PROTOCOLS>.
MORPHINE
1 mg/mL
SELECT DELIVERY MODE
PCA ONLY
PCA + CONT.
CONTINUOUS
PROTOCOLS
PREVIOUS
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5- 18 5) Select Mode
MORPHINE
PRESS ENTER
TO SELECT
PCA DOSE
LOCKOUT
4HOUR LIMIT
NEXT PROTOCOL
3
MORPHINE
PCA ONLY
PCA DOSE
LOCKOUT
4HOUR LIMIT
10 min
NONE
PREVIOUS#
1 mg/mL
10 min
NONE
CONFIRM
PREVIOUS

5.6 Dose Limit (1 or 4 hour)

2 mg
2 mg
15) Press to accept
ENTER
protocol, or select NEXT PROTOCOL> and PREVIOUS> to
view other stored protocols if available.
Press PREVIOUS> to return to the previous display.
16) Select CONFIRM> to accept settings of chosen protocol.
17) Close and lock door.
18) Press button to begin chosen Protocol.

DOSE LIMIT CALCULATION

The dose limit is a physician prescribed value that serves to limit the total dosage that can be delivered in any 4 hr (or 1 hr) period. This optional feature provides added safety to limit the total drug delivered in all delivery modes.
NOTE: The PCA 3 is factory set for programming a 4 hr dose limit. However, it can be changed to a 1 hr dose limit setting by a qualified biomedical person. For the purpose of simplifying this section, it will be written for 4 hr dose limit programming.
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LifeCare PCA 3 Infusion System 5- 19
NOTE: A loading or supplemental loading dose is included in the 4 hr dose limit calculation ONLY if it is administered AFTER the 4 hr dose limit has been programmed. If a loading or supplemental loading dose is administered BEFORE a 4 hr dose limit has been programmed, it will NOT be included in the 4 hr dose limit calculation. The loading and/or supplemental loading dose(s) is always included in the total for dose delivered.
When the sum of all doses (PCA dose, CONTINUOUS dose, and any applicable loading or supplemental loading dose) in the rolling 4 hour period equals or exceeds the 4 hr dose limit, patient requests for doses are unsuccessful and a "4 HR LIMIT REACHED" message appears. In all modes, the pump stops delivery when the 4 hr dose limit is reached, except during administration and delivery of a supplemental loading dose. A supplemental loading dose can be delivered anytime during setup or operation, even if the dose limit has already been reached (as indicated by a “4 HR LIMIT REACHED” message) or will be exceeded after delivery.
As the oldest dose (either PCA dose, CONTINUOUS dose, or a supplemental loading dose) ages out of the 4 hour dose record, the “4 HR LIMIT REACHED” message will disappear. The pump will again accept patient initiated dose requests in PCA Only and PCA+CONTINUOUS modes (assuming the programmed PCA lockout interval has also elapsed) and resumes infusion at the continuous rate in the CONTINUOUS and PCA+CONTINUOUS modes.
NOTE: A loading dose or supplemental loading dose can be delivered anytime during setup or operation, even if the dose limit has already been reached or will be exceeded after delivery.
NOTE: Setting a new dose limit will not erase the previous dose history.
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5- 20 5) Select Mode

PROGRAMMING THE 4 (OR 1) HR DOSE LIMIT

The opportunity to program this feature is presented in two entry screens. The first screen prompts the clinician to choose whether or not to set a Dose Limit. Selecting N No Dose Limit screen. Selecting Y
O> will bring up the Confirm
ES> will bring up the Dose Limit
Enter Value screen, requiring the clinician to enter a value within the displayed range.

TO PROGRAM A DOSE LIMIT:

MORPHINE
1 mg/mL
SET A DOSE LIMIT?
1) Select YES> at the Dose Limit Selection screen.
The display will advance to the Dose Limit Enter Value screen.
YES
NO
PREVIOUS
MORPHINE
1 mg/mL
ENTER 4 HOUR DOSE LIMIT THEN PRESS ENTER BUTTON
0.5-80 mg
0 mg
milligrams
2) Enter the 4 HR Dose Limit value using the numeric keypad (the value range is displayed on the screen).
NOTE: Entry of “0” for the 4 HR
Dose Limit, using the numeric keypad, is NOT accepted by the
PREVIOUS
PCA 3. If appropriate, see instructions for programming NO Dose Limit on the following page.
3) Then press .
ENTER
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LifeCare PCA 3 Infusion System 5- 21

TO PROGRAM NO DOSE LIMIT:

1) Select NO> at the Dose Limit Selection screen.
The display will advance to the Confirm No Dose Limit screen.
2) Select CONFIRM> to confirm the selection of No Dose limit.
NOTE: When NO LIMIT has been
programmed, the message “NO 4 HR LIMIT” will be displayed after the door has been locked.
MORPHINE
1 mg/mL
SET A DOSE LIMIT?
PREVIOUS
MORPHINE
1 mg/mL
CONFIRM NO DOSE LIMIT
CONFIRM
PREVIOUS
YES
NO
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TO CLEAR OR CHANGE DOSE LIMIT

MORPHINE
1 mg/mL PAUSED
PCA+CONT
LOCK DOOR
TO BEGIN
REVIEW RX
CHANGE RX
CLEAR SHIFT
LOADING DOSE
1) Unlock door while pump is running.
2) Select CHANGE RX>.
3) Select NEXT> to display more change options.
4) Select DOSE LIMIT>.
5) Set a specific dose limit by selecting YES> and advancing to the Dose Limit Enter Value screen.
Or, select NO> to choose No Dose Limit.
No Dose Limit will be selected for this example.
6) Select CONFIRM> to confirm the No Dose Limit selection.
Or, select PREVIOUS> to return to the previous screen.
7) Press SAVE & EXIT> at the next screen. This will bring up the Program Review screen.
8) Press C
ONFIRM> to accept new program.
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CLEARING THE HISTORY & RX SETTINGS

To clear the dose limit history, turn the pump off and on, and press C AND Rx" screen appears.
ONFIRM> when the "CONFIRM TO CLEAR HISTORY
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5.7 Using Review Screens

REVIEW SCREENS

Prior to locking the pump and removing the key, a review screen will appear as shown below. As determined by the programmed mode of delivery, the screen will display the current settings for the applicable parameters (including PCA Dose, Lockout Interval, Continuous Rate, and 4 (1) Hr Dose Limit)
.
MORPHINE
1 mg/mL
PCA+CONT
PCA DOSE
2 mg
LOCKOUT
10 min
CONT. RATE
2 mg/hr
4 HOUR LIMIT
NONE
CONFIRM
PREVIOUS
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Clinicians should review each programmed parameter and ensure that the displayed pro­gram agrees with the physician’s order.
If all of the programmed parameters AGREE
with the physician’s order, the clinician can confirm the settings by selecting CONFIRM>.
If one or more of the programmed parameters do not agree with the physician’s order, the clinician should select PREVIOUS> until the incorrectly programmed parameter(s) is dis­played. Depending on the parameter(s) that is incorrect, the programmed values can be changed by either entering the new value by using the numeric keypad and pressing [ENTER] or selecting the new setting using the appropriate S ate parameters have been changed, the review screen will be presented again. The clinician should review each setting to ensure agreement with the physician’s order.
Once CONFIRM> has been selected, the clini- cian should close and lock the door.
Place the key in a secure location.
Upon locking the door, PCA is available if the mode is set on either PCA ONLY or PCA + CONTINUOUS. If mode is set for PCA + CON­TINUOUS or CONTINUOUS, therapy will begin after pressing [START/PAUSE].
OFTKEY>. Once the appropri-

5.8 Changing Settings During Setup

During setup, select PREVIOUS> to return to the previous display and enter desired setting. Each time P message display will revert to the previous setting, until the first setting is displayed.
REVIOUS> is selected, the
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5.9 Stopping Infusion or Turning Pump OFF

STOPPING INFUSION

1) Close slide clamp on PCA administration set.
WARNING
ALWAYS CLOSE SLIDE CLAMP ON PCA ADMINISTRATION SET BEFORE REMOVING OR REPLACING SYRINGE, AND BEFORE DISCONTINUING INFUSION
2) Unlock door.
3) Or, press for Continuous or PCA + Continuous.
NOTE: If paused longer than two minutes without
pressing an appropriate key, the pump will alarm.

TO TURN PUMP OFF

1) Close slide clamp on PCA administration set.
2) Unlock door.
3) Press button
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5.10 Making Changes After Setup

TO REVIEW CURRENT SETTINGS

WHILE INFUSION IS RUNNING
1) Press button twice.
2) Press to return to main menu.
EXIT
WHILE INFUSION IS STOPPED
1) Unlock door.
2) Select REVIEW RX> to review all current settings.
3) Press to return to
EXIT
main menu.
4) Close and lock door and place key in a secure spot.
MORPHINE
1 mg/mL PAUSED
PCA+CONT
LOCK DOOR TO BEGIN
REVIEW RX
CHANGE RX
CLEAR SHIFT
LOADING DOSE
MORPHINE
1 mg/mL
PCA+CONT
PCA DOSE
LOCKOUT
CONT. RATE
4 HOUR LIMIT
5) Press to begin infusion.
PREVIOUS
2 mg
10 min
2 mg/hr
NONE
Or, select PREVIOUS> to return to previous display.
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TO CHANGE SETTINGS

MORPHINE
1 mg/mL PAUSED
PCA+CONT
LOCK DOOR
TO BEGIN
REVIEW RX
CHANGE RX
CLEAR SHIFT
LOADING DOSE
MORPHINE
1 mg/mL
SELECT SETTING
TO CHANGE
PCA DOSE
LOCKOUT
CONT. RATE
NEXT
SAVE & EXIT
1) Unlock door while pump is running.
2) Select CHANGE RX> to change individual settings.
3) Select desired field to change. (EXAMPLE PCA DOSE>)
Or, select NEXT> to display more change options, such as Mode of delivery and Dose Limit.
If Mode of delivery is changed, the display will prompt you to reprogram using the same steps as outlined in the beginning of this section.
The value previously set for the PCA dose will be flashing.
MORPHINE
1 mg/mL
ENTER
PCA DOSE
THEN PRESS
ENTER BUTTON
0.1-5 mg
2 mg
milligrams
PREVIOUS
4) Enter the desired PCA dose using the numeric keypad. (Value range is displayed on screen)
C
If value is entered incorrectly, press to change value.
5) Then press .
ENTER
L R
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If programming changes need to be made, select PREVIOUS> to return to the previous screen.
6) Select SAVE & EXIT> at next screen to confirm desired changes.
7) Select CONFIRM> to accept new program.
MORPHINE
1 mg/mL
PCA ONLY
PCA DOSE
LOCKOUT
4HOUR LIMIT
CONFIRM
PREVIOUS
2 mg
10 min
NONE

TO CLEAR SHIFT TOTALS

1) Review & record shift totals using the button before clearing.
2) Unlock door while pump is running.
3) Select CLEAR SHIFT> to display option to clear total dose delivered.
MORPHINE
1 mg/mL PAUSED
PCA+CONT
LOCK DOOR TO BEGIN
REVIEW RX
CHANGE RX
CLEAR SHIFT
LOADING DOSE
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MORPHINE
1 mg/mL
CLEAR SHIFT
TOTALS?
YES
NO
4) Select YES> to clear dose delivered and return to previous screen.
NOTE: Selecting YES> will clear
PCA Summary data but does not clear 4HR dose limit data
5) Or, select NO> to return to previous screen.

TO CHANGE A VIAL

1) The alarm message “EMPTY SYRINGE” appears along with the statement “REPLACE SYRINGE”.
2) Close slide clamp on PCA administration set.
3) Press button.
4) Insert key and lock door.
Screen displays infuser is “PAUSED”.
5) Remove old vial by firmly grasping glass vial on both sides and pull­ing straight out.
6) Load in new vial as shown before. (See Section 4.3)
The Review Confirmation Screen appears.
7) Select CONFIRM>.
8) Select NO> when “Clear History and Rx Settings” is displayed.
9) Select
YES> when “Purge” is displayed.
WARNING
PATIENT MUST BE DISCONNECTED FROM THE PCA SET BEFORE THE PURGE CYCLE.
10) At this point, you must:
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LifeCare PCA 3 Infusion System 5- 31
disconnect the set from the patient
release the slide clamp on the PCA adminis­tration set
select & hold the Purge> key until fluid is seen at the end of the set and no air remains inside the set
NOTE: Purging is recommended to remove slack when a new vial is
inserted. The system must be primed before purging. The maximum volume delivered during a purge is 3 mL.
NOTE: Drug delivered during purge cycle is NOT stored in system memory and will not be displayed.
CAUTION: IN CONTINUOUS
MODES, IF A PURGE IS NOT PERFORMED AFTER A SYRINGE
,
CHANGE SYSTEM
[START] IS
FLUID THE DISCONNECTED
THE PUMP AUTOMATICALLY PERFORMS A SMALL
COMPLIANCE STEP TO REMOVE SLACK WHEN
PRESSED (WITH DOORS LOCKED
IS
NOT NORMALLY DELIVERED TO THE PATIENT DURING
COMPLIANCE STEP, IT IS RECOMMENDED THAT THE SET BE
FROM THE PATIENT DURING THIS OPERATION
AND
PCA+CONTINUOUS
). A
LTHOUGH
.
Upon release of the PURGE> softkey, the display will ask
if the purge is complete.
11 ) S e l e c t YES> to continue, or select NO> to purge again until complete.
12) Reconnect the set to the patient.
13 ) S e l e c t
YES> to retain the current Rx settings (unless you are
changing the Rx settings).
The Review Confirmation Screen appears.
14) Review the entered parameters, and if correct, select CONFIRM>.
15) Close and lock door to begin infusion. Press the button if in the Continuous or PCA+Continuous mode.
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TO ADD A SUPPLEMENTAL LOADING DOSE

MORPHINE
1 mg/mL PAUSED
PCA+CONT
LOCK DOOR
TO BEGIN
REVIEW RX
CHANGE RX
CLEAR SHIFT
LOADING DOSE
MORPHINE
1 mg/mL
ENTER
LOADING DOSE
THEN PRESS
ENTER BUTTON
0.1 - 10 mg
5 mg
milligrams
PREVIOUS
MORPHINE
1 mg/mL
PRESS
START BUTTON TO INFUSE 5 MG LOADING DOSE
1) Unlock door while pump is running.
2) Select LOADING DOSE>.
3) Enter a Loading Dose within the displayed range.
4) Then press .
ENTER
5) Press to infuse loading dose.
PREVIOUS
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5.11 Checking History & Settings

1) To Check History or Settings, press button at any time.
NOTE: Partial boluses can be the result of interrupting
delivery by pressing [START/STOP] (PCA + Cont.), opening the door (PCA Only), loss of power, reaching the dose limit, emptying the vial, or a malfunction alarm.
2) Press or button
ENTER
to scroll through history. Or select PRINT HISTORY> to print (if connected to printer).
3) Press or button
ENTER
a second time for more information.
When MORE is displayed, more information is stored in pump history.
PRESS HISTORY OR ENTER BUTTON TO SCROLL THROUGH HISTORY
PRINT HISTORY
MORPHINE
1 mg/mL
PCA+CONT
PCA DOSE
LOCKOUT
CONT. RATE
4 HOUR LIMIT
MORE...
PREVIOUS
0.5 mg
5 min
10 mg/hr
NONE
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TIME : 8:04 PM DATE : 01/15/01 S/N:12920191
DELIVERED:
4) Continue to press or
ENTER
button for more
information such as:
LOADING DOSE
TOTAL DEL.
MORE...
65 MG
282.6 MG
PREVIOUS
events may be logged.
5) Press to return to the Main Delivery
EXIT
•Last Hour Only information
•Last 24-Hour information
•Event Log
Event Log allows you to view all events since last Clear History. Up to 400
screen.

5.12 Printer Setup

The PCA3 is configured to communicate with a serial printer or communications link. The required serial settings are:
9600 baud
8 bit data
no parity.
To configure a Seiko Instruments SII DPU-414 Thermal Printer, the settings are controlled on power-up using two panel control switches:
[PAPER FEED]= OFF
[ON LINE]= ON).
The Seiko printer also has other configuration settings that relate to the control and formatting of the printer. To set any one feature, all the features need to be set in a series of yes/no/continue inputs using just the two controls. This may be a little tedious, but once set, the printer is ready for use.
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To program the Seiko printer, hold the "ONLINE" button while turning on the power. The printer will then display (on the paper tape output) the configuration it has stored in memory, and prompt the user for input. The print-out of the user settings should look like the following:
[DIP SW setting mode]
Dip SW-1 1 (OFF) : Input = Serial 2 (ON ) : Printing Speed = High 3 (ON ) : Auto Loading = ON 4 (OFF) : Auto LF = OFF 5 (ON ) : Setting Command = Enable 6 (OFF) : Printing 7 (ON ) : Density 8 (ON ) : = 100 % Dip SW-2 1 (ON ) : Printing Columns = 40 2 (ON ) : User Font Back-up = ON 3 (ON ) : Character Select = Normal 4 (ON ) : Zero = Normal 5 (ON ) : International 6 (ON ) : Character 7 (ON ) : Set 8 (OFF) : = U.S.A. Dip SW-3 1 (ON ) : Data Length = 8 bits 2 (ON ) : Parity Setting = No 3 (ON ) : Parity Condition = Odd 4 (ON ) : Busy Control = H/W Busy 5 (OFF) : Buad 6 (ON ) : Rate 7 (ON ) : Select 8 (ON ) : = 9600 bps
Continue ? : Push 'On-line SW' Write ? : Push 'Paper feed SW"
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If the above is already configured, press the [PAPER FEED], and the printer will display :
DIP SW settings complete !!
If the above is not displayed correctly with the PCA3, or may print gibberish. To make any change, all the settings for that DIP SW need to be made as a block of entries using the [ONLINE] button for ON, and [PAPER FEED] button for OFF. Pressing the [ONLINE button at this point begins the entry process for the first DIP SW. To access DIP SW 2 or 3, all the entries for the earlier settings need to be duplicated in sequence. Once the desired DIP SW has a complete set, pressing the [PAPER FEED] button when prompted, finishes the process.
From power-up, to setup as shown above, required user input is:
1. Press and hold [ONLINE] while turning on power.
Wait for user prompt.
2. Press [ONLINE] to begin setup
The printout should read:
Dip SW-1
The printer is now waiting for a entry for the first position (Input Method: Serial). This functional setting should be OFF, so:
, the printer may not communicate
3. Press [PAPER FEED] button
The printout should then read:
DIP SW-1
1 (OFF) : Input = Serial
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4. The remainder of the settings are then entered, pressing [ONLINE] for ON, and [PAPER FEED] for OFF. This is done sequentially for ALL 24 fields [DIP SW-1(8), 2(8), & 3(8)]. The remainder of settings should be set as follows, continuing with SW1-2:
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REQUIRED PRINTER SETTINGS TO OPERATE WITH PCA 3
Switch Function Setting Button to Press
SW1-1 Input Method: Serial Off Feed
SW1-2 Printing Speed: High On On line
SW1-3 Auto loading: On On On line
SW1-4 Auto LF: Off Off Feed
SW1-5 DIP SW setting command: Enabled On On line
SW1-6 Printing density: 100% Off Feed
SW1-7 Printing density: 100% On On line
SW1-8 Printing density: 100% On On line
SW2-1 Print Mode: 40 columns On On line
SW2-2 User font back-up: On On On line
SW2-3 Character select: Normal On On line
SW2-4 Zero font: Normal On On line
SW2-5 Int’l Character Set: American On On line
SW2-6 Int’l Character Set: American On On line
SW2-7 Int’l Character Set: American On On line
SW2-8 Int’l Character Set: American Off Feed
SW3-1 Data bit length: 8 bits On On line
SW3-2 Parity: No parity On On line
SW3-3 Parity condition: Odd On On line
SW3-4 Flow control: H/S busy On On line
SW3-5 Baud rate: 9600 bps Of f Feed
SW3-6 Baud rate: 9600 bps On On line
SW3-7 Baud rate: 9600 bps On On line
SW3-8 Baud rate: 9600 bps On On line
Continue ? : Push 'On-line SW'
Write ? : Push 'Paper feed SW"
5. Press FEED
DIP SW setting complete !!
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5.13 Printing Event History Log

The history event log can be printed by connecting the pump to a Seiko Instruments SII DPU-414 thermal printer, using the previous instructions. Two custom printer cables are available. They are not interchangeable.
WARNING
DISCONNECT THE PUMP FROM THE PATIENT BEFORE CONNECTING THE PUMP TO A PRINTER OR COMPUTER.
To print from the PCA 3, complete the following steps:
1. Load printer with test paper.
2. Plug in AC adapter.
3. Press and hold ONLINE while turning ON power.
4. Review the printout of configured settings against the previous table. If they match, you’re ready to print. If they do not match, reconfigure as explained in the previous section.
5. Connect the printer to the PCA 3 using a 9-pin male to 9­pin female cable. Contact Customer Service for
information on printer connector cables.
6. Print whenever the PCA 3 offers the P option.
RINT> softkey
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5.14 Downloading to a PC

EQUIPMENT NEEDED

•Pump
Computer with Windows 3.1 or Windows 95/98/ NT/2000
Standard Printing Cable
25-pin to 9-pin converter
Null Modem Adapter

PUMP TO WINDOWS 95, 98, NT OR 2000

INITIAL HYPER TERMINAL ACCESS- CREATING A NEW CONNECTION
1. Select the Start menu.
2. Select Programs.
3. Select Accessories.
4. Select HyperTerminal.
5. Double-click on the HyperTerminal icon.
6. If a message box appears indicating that a modem is necessary for a connection, click NO.
7. In the Connection Description box, enter the name which to save the settings.
8. Click OK.
9. In the Phone Number box, select Direct to Com 2 from the Connect Using Drop Down list.
10. Click OK.
11. In the COM Port properties window, set the Bits Per Second to 9600 and Flow Control to None.
12. Click OK.
13. Select the Propertied icon. (farthest to right)
14. Select the Settings tab.
15. Select the ASCII setup button.
16. Make sure ‘Append line feeds to incoming line ends’ is not checked.
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17. Click OK in the ASCII setup window.
18. Click OK in the properties window.
19. Select File from the menu bar.
20. Select Save from the file menu.
HYPERTERMINAL ACCESS- USING AN EXISTING CONNECTION
1. Select the Start Menu.
2. Select Programs.
3. Select Accessories.
4. Select HyperTerminal.
5. Double-click on the icon with the name entered in step #7 above.
PRINTING THE FILE
1. Select Call from the menu bar.
2. Select Connect from the Call menu.
3. Select Transfer from the menu bar.
4. Select Capture Test from the Transfer menu.
5. Type the Path To and the name of the file in which to save the printout. If the file name already exists, the newly transferred data will be appended to the end of the already existing file.
6. Click Start.
7. Select the desired print function from the group.
8. When the transmission of the data has completed, select Transfer from the menu bar.
9. Select Capture Text from the Transfer menu.
10. Select Stop from the Capture Text menu.
11. Select Call from the menu bar.
12. Select Disconnect from the Call menu.
13. Exit HyperTerminal
14. Pull up the file in your word processor of choice and print or view as desired.
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PRINT TO WINDOWS 3.1

INITIAL TERMINAL ACCESS- CREATING A NEW CONNECTION
1. Open the Accessories group.
2. Select Terminal from the Accessories group.
3. Select Settings from the menu bar.
4. Select Terminal Preferences from the Settings menu.
5. Make sure CR->CR/LF Inbound is not selected.
6. Click OK.
7. Select Settings from the menu bar.
8. Select Communications from the Settings menu.
9. Make sure Baud Rate is 9600, Data Bits are 8, Stop Bits 1, Parity is none, Xon/Xoff is selected, and COM 1 or 2 is selected.
10. Click OK.
11. Select File from the menu bar.
12. Select Save from the File menu.
13. Enter the name under which to save the settings.
14. Click OK.
TERMINAL ACCESS- USING AN EXISTING CONNECTION
1. Select the Accessories group.
2. Select Terminal
3. From File menu, select Open.
4. Select name of Connection Saved, click OK.
PRINTING THE FILE
1. Select Transfers from the menu bar.
2. Select Receive Text File from the Tranfers menu.
3. Type the Path To and the name of the file in which to save the printout.
4. Click OK.
5. Select the desired print function from the pump.
6. When the transmission of the data has completed, select Transfer from the menu bar.
7. Select Stop from the Transfers menu.
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